Cleared Traditional

REAL INTELLIGENCE? CORI? XT (CORI XT)

K252841 · Blue Belt Technologies, Inc. · Orthopedic

Dec 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K252841 is an FDA 510(k) clearance for the REAL INTELLIGENCE? CORI? XT (CORI XT), a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on December 5, 2025, 88 days after receiving the submission on September 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K252841 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2025
Decision Date	December 05, 2025
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.